UV SPECTROPHOTOMETRIC DETERMINATION OF RUPATADINE FUMARATE IN BULK AND TABLET DOSAGE FORM BY USING SINGLE POINT STANDARDIZATION METHOD

Abstract

Objective: To develop and validate a simple, selective, precise and accurate method for the estimation of rupatadine fumarate in bulk and tablet dosage form by using the single point standardization method as per international conference on harmonization (ICH) guidelines.

Methods: In this proposed method, the absorbance of a standard solution of known concentration and a sample solution was measured. From this, the concentration of the unknown can be calculated.

Results: Rupatadine fumarate showed maximum absorbance at 246 nm with methanol. Linearity was checked in different concentrations. The calibration curve was obtained in the range of 2-10 µg/ml. The slope, intercept and correlation coefficient (R²) values of Rupatadine fumarate were found to be 0.047, 0.0034 and 0.9995 respectively. Intra-day and inter-day precision studies were carried out and there % RSD values were found within limits i.e. less than 2%. The recovery studies were carried out by adding a known amount of standard drug to preanalysed formulation and % Recovery was found to be within 99.7-101.6%. LOD and LOQ of Rupatadine fumarate were found to be 0.1 µg/ml and 0.3 µg/ml respectively. Robustness studies were performed at different wavelengths and the % RSD was found within the limits i.e. less than 2 %.

Conclusion: The developed single point standardization method for the estimation of Rupatadine fumarate was found to be simple, precise, accurate, reproducible and cost-effective. Statistical analysis of the developed method confirms that the proposed method is an appropriate and it can be useful for the routine analysis. The proposed method gives the basic idea to the researcher who is working in the area like product development.